Monitor, Ultrasonic, Nonfetal
Radiology · 21 CFR 892.1540
Recent MDR events
80 adverse event reports on file
- UNETIXS VASCULARJan 4, 2023DeathUnetixs Vascular Inc0001222117-2023-60002
- MULTILAB SERIES II ERGO-IDCDec 19, 2022DeathUnetixs Vascular, IncMW5113854
- THD REVOLUTIONOct 25, 2022MalfunctionThd Spa3006680097-2022-00003
- THD REVOLUTIONMar 22, 2021MalfunctionThd Spa3006680097-2021-00002
- THD SLIDE ONENov 17, 2020MalfunctionThd Spa3006680097-2020-00003
- POCKET DOP IIMar 25, 2020MalfunctionNatus Neurology Incorporated3010611950-2020-00008
- THD SLIDE ONEMar 12, 2020MalfunctionThd Spa3006680097-2020-00002
- ELITE AUTO SHUT-OFF 200R MAINMar 11, 2020MalfunctionNatus Neurology Incorporated3010611950-2020-00003
- THD REVOLUTIONFeb 10, 2020MalfunctionThd Spa3006680097-2020-00001
- NICOLET ELITEDec 23, 2019MalfunctionNatus Neuro Incorporated3010611950-2019-00077
Event type breakdown
Recalls
8 recall events for this product code
- Unetixs Vascular, Inc.Open, ClassifiedMar 1, 2023
MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01
The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
Z-1193-2023 · View FDA record ↗ - Unetixs Vascular, Inc.Open, ClassifiedMar 1, 2023
MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01
The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
Z-1194-2023 · View FDA record ↗ - Unetixs Vascular, Inc.Open, ClassifiedMar 1, 2023
MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01
The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
Z-1195-2023 · View FDA record ↗ - Unetixs Vascular, Inc.Open, ClassifiedMar 1, 2023
MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01
The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
Z-1196-2023 · View FDA record ↗ - Natus Neurology IncTerminatedUnknown
Nicolet Elite 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog Code: N200.
Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood flow.
Z-2726-2017 · View FDA record ↗ - Natus Neurology IncTerminatedUnknown
Nicolet Elite 2 MHz OB Water Proof Probe, Model #: X1L008, Catalog Code: NW20.
Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood flow.
Z-2727-2017 · View FDA record ↗ - Natus Neurology IncTerminatedUnknown
Nicolet Elite 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300.
Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood flow.
Z-2728-2017 · View FDA record ↗ - Natus Neurology IncTerminatedUnknown
Nicolet Elite 5 MHz Vascular Probe, Model #: X1L004, Catalog Code: N500.
Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood flow.
Z-2729-2017 · View FDA record ↗
Registered firms
19 firms currently registered for this product code
Coopersurgical, Inc.
Trumbull, CT, US
Surgical Technologies, Inc.
ST. PAUL, MN, US
Unetixs Vascular, Inc.
Warwick, RI, US
Natus Neurology Incorporated
Middleton, WI, US
Imex, Llc
Fulton, MD, US
Koven Technology, Inc.
Saint Louis, MO, US
Thd Spa
Correggio Reggio Emilia, IT
Newman Medical
Arvada, CO, US
Microlab Elettronica
Ponte S. Nicolo Padova, IT
Huntleigh Healthcare Ltd.
CARDIFF, SOUTH GLAMORGAN, GB
Hadeco, Inc.
KAWASAKI Kanagawa, JP
510(k) clearances
38 clearances for this product code
- Laminar Digital Health, Inc.Dec 13, 2024
K242487 · Laminar P1 (LDH-HW-001)
- Thd SpaFeb 24, 2015
K141657 · THD REVOLUTION
- Newman MedicalMay 12, 2011
K110628 · SIMPLEABI
- Summit Doppler Systems, Inc.Dec 24, 2009
K093393 · LIFEDOP MODEL 300ABI
- Thd SpaJan 28, 2009
K090009 · THD SLIDE ONE
- Thd SpaJul 30, 2008
K081429 · THD SLIDE
- G.F. S.R.L.Jun 20, 2007
K070815 · THD
- Summit Doppler Systems, Inc.Dec 19, 2006
K063600 · VISTA AVS